Table 3 Local reactions at the PCV-7 and DTPa-HBV-IPV/Hib injection site within 4 days of vaccination – safety population
PCV-7 | DTPa-HBV-IPV/Hib | ||||||
|---|---|---|---|---|---|---|---|
Local reactions | Prophylaxis group% (n/N) | Control group% (n/N) | p-value* | Prophylaxis group% (n/N) | Control group% (n/N) | p-value* | |
Tenderness † | Dose 1 | 5.3 (6/114) | 12.9 (17/132) | 0.049 | 6.1 (7/114) | 11.5 (15/130) | 0.180 |
Dose 2 | 8.3 (10/120) | 14.4 (17/118) | 0.157 | 10.0 (12/120) | 15.4 (18/117) | 0.244 | |
Dose 3 | 5.5 (6/109) | 10.3 (11/107) | 0.216 | 6.4 (7/109) | 10.2 (11/108) | 0.337 | |
Toddler dose | 21.3 (20/94) | 32.7 (35/107) | 0.082 | 21.2 (21/99) | 29.9 (32/107) | 0.202 | |
Toddler dose/severe | 3.4 (3/88) | 5.1 (5/98) | 0.724 | 3.4 (3/88) | 3.1 (3/98) | >0.99 | |
Swelling ‡ | Dose 1 | 9.5 (11/116) | 17.2 (23/134) | 0.096 | 17.9 (21/117) | 18.2 (24/132) | >0.99 |
Dose 2 | 17.1 (21/123) | 27.2 (34/125) | 0.067 | 23.4 (29/124) | 34.6 (44/127) | 0.053 | |
Dose 3 | 16.8 (18/107) | 27.7 (31/112) | 0.074 | 21.8 (24/110) | 28.1 (32/114) | 0.355 | |
Toddler dose | 24.2 (23/95) | 33.3 (35/105) | 0.164 | 37.3 (38/102) | 37.5 (39/104) | >0.99 | |
Redness ‡ | Dose 1 | 22.5 (27/120) | 27.2 (37/136) | 0.470 | 20.8 (25/120) | 23.7 (31/131) | 0.650 |
Dose 1/severe | 0.9 (1/114) | 0 | 0.475 | 0.9 (1/114) | 0 | 0.475 | |
Dose 2 | 21.1 (26/123) | 34.9 (44/126) | 0.017 | 30.4 (38/125) | 40.6 (52/128) | 0.115 | |
Dose 3 | 25.4 (29/114) | 34.8 (39/112) | 0.147 | 28.9 (33/114) | 34.2 (39/114) | 0.476 | |
Toddler dose | 34.7 (35/101) | 44.4 (48/108) | 0.160 | 44.2 (46/104) | 48.1 (51/106) | 0.583 | |